Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Clinical Data Team Lead – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Clinical Data Team Lead, you will act as the lead data manager for one or more projects or provide support to the lead data manager. You may lead all data management activities for individual, limited volume/complexity studies with support from senior team members. Additionally, you will act as an interdepartmental and client liaison for all data management study activities.
What You’ll Do:
Applies relevant components of the project protocol to daily tasks and directs others on how to apply to their daily tasks.
Acts as a liaison to the Project Lead and/or client as required and communicates with management regarding all data management (DM) activities within their studies.
Develops and maintains data management project documentation files; performs independent reviews of data management deliverables following documented CDM guidelines.
Develops and delivers study specific training for DM project staff.
Produces project-specific status reports for management, Project Lead and/or clients on a regular basis. Monitors study metrics.
May participate in business development activities by assisting with bid preparation and/or representing data management at bid defense meetings, where required.
Assists with project forecasting of hours and identification of resource requirements and identifies potential out of scope activities to Project Lead and management and assists with the Contract Modification process.
Mentors junior level staff on all associated tasks within a study.
Assists with the administrative and financial management of allocated projects. Performs all assigned data management activities independently and efficiently, with attention to quality.
Education and Experience Requirements:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations
Ability to use interactive computer programs
Good written/ verbal communication skills with a strong command of English language and grammar; good organizational, analytical/problem solving skills and attention to detail
Ability to work productively with minimal supervision
Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
Strong customer focus and excellent interpersonal skills
Proven flexibility and adaptability
Ability to work in a team environment and independently as needed
Ability to train and direct study team
Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands
Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs.
Thermo Fisher Scientific is a global life sciences company that enables customers to make the world healthier, cleaner, and safer through innovative scientific solutions. The company operates multiple business divisions including the Microbiology Division and Drug Substance Division (PSG), providing advanced technologies and services for clinical, pharmaceutical manufacturing, and biopharmaceutical applications. Thermo Fisher develops solutions across life sciences, healthcare, and scientific instruments industries, addressing major global challenges such as environmental protection, food safety, and medical research including cancer cures. The company maintains a sophisticated matrix organization with operations across multiple continents including sites in North America, Europe, and Australia.
